Back Pain Lower Back ChronicNCT05386212
The Impact of an Instructional Web-based Healthcare App for Relieving Back Pain From Spinal Compression Fractures
An observational study of Back Pain Lower Back Chronic, run by National Taipei University of Nursing and Health Sciences at 3 sites in Taiwan.
Trial summary
With the expected rise of patients with osteoporosis-induced fractures, it has become increasingly urgent to design and use specialized health education materials aimed at easing pain and improving bodily functions Read more about this study
- Who is it for?
- Ages 45 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Back Pain Lower Back Chronic
- What is being tested?
- web app healthcare instructions for relieving back pain
- Type of treatment
- Medical device
- How many people
- 250 participants
- Where
- 3 sitesTaiwan
- Study dates
- 12 May 2022to 1 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: postmenopausal women
Who may be able to join
- postmenopausal women
Who cannot join
- postmenopausal women
Trial locations and contacts
3 sites in 1 country.
Taiwan3 sites
National Taipei university of nursing and health science
Taipei, Peito, 112
Cheng Hsin General Hospital
Taipei
National Taipei university of nursing and health science
Taipei
About this study
Official title: National Taipei University of Nursing and Health Science
With the expected rise of patients with osteoporosis-induced fractures, it has become increasingly urgent to design and use specialized health education materials aimed at easing pain and improving bodily functions
Read the detailed description
This study designed web-based dynamic pain relief instructions for women with spinal compression fractures. We collected patients' pain rating data the day before, one month after, and three months after providing the instructions.
- Conditions
- Back Pain Lower Back Chronic
- Being tested
- web app healthcare instructions for relieving back pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
web app healthcare instructions for relieving back painDevice
This study designed web-based dynamic pain relief instructions for women with spinal compression fractures.
| Study group | Role | What they receive |
|---|---|---|
| control | regular nursing care instructions Receives: Device: web app healthcare instructions for relieving back pain | |
| Expirement | web app healthcare instructions for relieving back pain Receives: Device: web app healthcare instructions for relieving back pain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of back pain, and qualitative of life between groups
Follow-up observations of the control and experimental groups one month after the f intervention, as well as a significant difference between the data collected prior to the intervention and two months after the intervention
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2022
- Study start12 May 2022
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Back Pain Lower Back ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taipei University of Nursing and Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Cheng-Hsin General Hospital
- Responsible party
- Principal investigator, Pei-Hung Liao, National Taipei University of Nursing and Health Sciences
- Investigators
- Pei-Hung Liao, Principal investigator, National Taipei University of Nursing and Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05386212
- Sponsor's protocol ID
- 108A-16
- Status last verified
- May 2022
- First submitted
- 10 May 2022
- Last updated
- 23 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Taipei University of Nursing and Health Science
- ClinicalTrials.gov ID
- NCT05386212
- Acronym / sponsor ID
- 108A-16
- Conditions
- Back Pain Lower Back Chronic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- National Taipei University of Nursing and Health SciencesUniversity, hospital or other
- Collaborators
- Cheng-Hsin General Hospital
- Study start
- 12 May 2022 (actual)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 23 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
With the expected rise of patients with osteoporosis-induced fractures, it has become increasingly urgent to design and use specialized health education materials aimed at easing pain and improving bodily functions
Detailed description
This study designed web-based dynamic pain relief instructions for women with spinal compression fractures. We collected patients' pain rating data the day before, one month after, and three months after providing the instructions.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | – | Device: web app healthcare instructions for relieving back painregular nursing care instructions |
| Expirement | – | Device: web app healthcare instructions for relieving back painweb app healthcare instructions for relieving back pain |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- postmenopausal women
Key inclusion criteria (1 listed)
- postmenopausal women
Key exclusion criteria (1 listed)
- postmenopausal women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| web app healthcare instructions for relieving back painThis study designed web-based dynamic pain relief instructions for women with spinal compression fractures. | Device | Expirement, control |
Primary outcome
Comparison of back pain, and qualitative of life between groups
Time frame: 3 months
Follow-up observations of the control and experimental groups one month after the f intervention, as well as a significant difference between the data collected prior to the intervention and two months after the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pei-Hung Liao principal investigator
National Taipei University of Nursing and Health Sciences
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Back Pain Lower Back Chronic, run by National Taipei University of Nursing and Health Sciences at 3 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of back pain, and qualitative of life between groups (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2022.